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YY 0581.1-2011: Infusion access adapters. Part 1: Needle access adapters(Heparin plugs)
Status: Obsolete YY 0581.1: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY 0581.1-2011 | English | 439 |
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Infusion access adapters. Part 1: Needle access adapters(Heparin plugs)
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YY 0581.1-2011
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| YY 0581-2005 | English | 359 |
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Heparin plugs for infusion
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YY 0581-2005
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Basic data | Standard ID | YY 0581.1-2011 (YY0581.1-2011) | | Description (Translated English) | Infusion access adapters. Part 1: Needle access adapters(Heparin plugs) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.040.20 | | Word Count Estimation | 11,128 | | Date of Issue | 2011-12-31 | | Date of Implementation | 2013-06-01 | | Older Standard (superseded by this standard) | YY 0581-2005 | | Quoted Standard | GB/T 1952.2; GB 8368; GB 15810; GB 15811; YY/T 0466.1 | | Regulation (derived from) | State Food and Drug Administration Notice 2011 No. 106; industry standard filing Notice 2013 No. 6 (No. 162 overall) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the piercing infusion connector (also known as heparin cap, hereinafter referred to as: connections) requirements and test methods. Connections with indwelling intravascular devices (eg intravenous catheter) are integrated supply products, you can refer to the implementation of this section. | YY 0581.1-2011: Infusion access adapters. Part 1: Needle access adapters(Heparin plugs)---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Infusion access adapters.Part 1. Needle access adapters (Heparin plugs)
ICS 11.040.20
C31
People's Republic of China pharmaceutical industry standards
Infusion connector
Part 1. piercing connector (heparin cap)
Part 1. Needleaccessadapters (Heparinplugs)
Issued on. 2011-12-31
2013-06-01 implementation
State Food and Drug Administration issued
Foreword
YY 0581 "infusion connector" is divided into two parts.
--- Part 1. piercing connector (heparin cap);
--- Part 2. needle-free connectors.
This is Part 1 YY 0581 of.
This section drafted in accordance with GB/T 1.1-2009 given rules.
YY 0581 This part of Amendment YY 0581-2005. The main difference between this part and the YY 0581-2005 YY 0581 are.
--- Modify the standard name;
--- Modify the chemical test methods;
Increase the volume of the cavity --- labeling requirements on a single package.
This part is proposed by the State Food and Drug Administration.
This part of the National Technical Committee of Standardization for medical infusion set (SAC/TC106) centralized.
This section is drafted. Shandong Medical Devices Product Quality Inspection Center.
Drafters of this section. Wan Min, Liu Bin, Liu Ye.
Introduction
Common market infusion into piercing connectors (also known as pin connectors have) and non-penetrating formula (also known as needle-free connection) of two types. foreign
On the market there is a blunt plastic pin connector type connections. Interface and after use to maintain its sealing its total requirement. Piercing
Connector interface for patients with puncture risk off the crumbs into the infusion system, as well as medical staff have needle prick accident risk; non-punch
Barbed connector member such risks piercing connection does not exist, but there is the risk of multiple uses microbial invasion infusion system.
Infusion connector YY 0581 relates generally intravascular long-term use of indwelling catheters (eg intravenous catheter, central venous catheters)
With the use, through which the liquid to the intravascular infusion and extraction of blood or liquid. Whether the use of needles or needle-free connection is connected, at the output
At the end of the infusion liquid or liquid between different, it must be made in physiological saline via infusion catheter flushing pipe fittings, flush left in the catheter
Drugs to prevent complications such as phlebitis. At the end of the infusion with saline or heparin saline through
Pin connector, or needleless connectors on the catheter forward sealed tube to prevent backflow of blood transfusion due to pull out when the appliance caused.
Prolonged use in connection with intravascular indwelling catheter if improper connections between, there is the risk of accidental loss, which may cause
Patients with massive bleeding into the patient and endanger their lives. Therefore, the lock connector and require clinical use is to maintain a reliable connection
Necessary, recommendations on joint injection or related product packaging or instructions for use on the reliability of the connection holding given the necessary warnings.
GB 8368 "disposable infusion gravity infusion formula" in the relevant appendix NA applies YY 0581 this section.
Infusion connector
Part 1. piercing connector (heparin cap)
1 Scope
YY 0581 This section provides puncture infusion connectors (also known as heparin cap, hereinafter referred to as. connections) requirements and test methods.
Connection with indwelling intravascular devices (such as intravenous catheter) into one integrated product supply, can refer to the implementation of this section.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 1962.2 syringes, needles and other medical equipment - 6% (Luer) taper fittings - Part 2. Lock fittings
GB 8368 disposable infusion set gravity transfusion formula
GB 15810 single-use sterile syringes
GB 15811-time use of sterile needles
Symbols - Part 1 YY/T 0466.1 medical equipment used with medical device labels, labeling and information. General requirements
3 Mark
Infusion connector marked by the text and description of the part number, numbered.
Connection YY 0581.1
4 Materials
Material connecting member shall meet the requirements specified in Chapter 5, 6 and 7.
5 Physical Requirements
5.1 particulate pollution
Liquid passage surface of the connecting member should be clean. When you press A.1 prescribed test shall not exceed the pollution index.
5.2 connection strength
Press A.2 predetermined test connections and all connections between components should be able to withstand at least 15N static pull 15s.
5.3 Leak
Connections shall not permeable to air and liquid. When you press the test A.3 provisions, there should be no air or water leaks.
5.4 connector
If there is a 6% (Luer) taper joint on the connecting member for use in connection with indwelling catheters in the other vessel, which should be a joint operator
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